Endoscopic Injection Sclerotherapy Versus N-butyl-2-cyanoacrylate Injection

NCT ID: NCT03388125

Last Updated: 2018-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

113 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-01

Study Completion Date

2022-12-01

Brief Summary

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Endoscopic Injection Sclerotherapy vs N-butyl-2-cyanoacrylate Injection

Detailed Description

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Endoscopic Injection Sclerotherapy versus N-butyl-2-cyanoacrylate Injection in the Management of Actively Bleeding Esophageal Varices

Conditions

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Bleeding Esophageal Varices

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Injection Sclerotherapy

5% ethano lamine oleate

Group Type ACTIVE_COMPARATOR

Injection Sclerotherapy

Intervention Type DRUG

5% ethanolamine oleate group

N-butyl-2-cyanoacrylate

N-butyl-2-cyanoacrylate injection group

Group Type ACTIVE_COMPARATOR

N-butyl-2-cyanoacrylate

Intervention Type DRUG

N-butyl-2-cyanoacrylate injection group

Interventions

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Injection Sclerotherapy

5% ethanolamine oleate group

Intervention Type DRUG

N-butyl-2-cyanoacrylate

N-butyl-2-cyanoacrylate injection group

Intervention Type DRUG

Other Intervention Names

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5% ethanolamine oleate

Eligibility Criteria

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Inclusion Criteria

* cirrhotic patients presented with actively bleeding

Exclusion Criteria

* other sources of UGIB than esophageal varices, hepatic encephalopathy or hepatocellular carcinoma (HCC)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sherief Abd-Elsalam

OTHER

Sponsor Role lead

Responsible Party

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Sherief Abd-Elsalam

Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Mohamed Alsebaey, MD

Role: PRINCIPAL_INVESTIGATOR

Gastroenterology

Mohamed Abdelraouf, MD

Role: STUDY_DIRECTOR

Gastroenterology

Sherief Abd-Elsalam, MD

Role: STUDY_DIRECTOR

Hepatology and Gastroenterology

Locations

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Sherief Abd-Elsalam

Tanta, , Egypt

Site Status

Countries

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Egypt

References

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Elsebaey MA, Tawfik MA, Ezzat S, Selim A, Elashry H, Abd-Elsalam S. Endoscopic injection sclerotherapy versus N-Butyl-2 Cyanoacrylate injection in the management of actively bleeding esophageal varices: a randomized controlled trial. BMC Gastroenterol. 2019 Feb 4;19(1):23. doi: 10.1186/s12876-019-0940-1.

Reference Type DERIVED
PMID: 30717684 (View on PubMed)

Other Identifiers

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Active bleeding

Identifier Type: -

Identifier Source: org_study_id

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